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A real-world evidence (RWE) retrospective review from UK hospital patient records

MANCHESTER (SALFORD): 164 patients from a tertiary centre, review at 3 and 6 months2,3

MANCHESTER (SALFORD)3
(N=164)
Median age (years) 36 (18–87)
Males (%) 59.75
Median baseline EASI Score 23 ± 16
Median baseline DLQI Score 22 ± 10

Proportion of patients achieving EASI-50, EASI-75 and EASI-902-4

In Manchester at 6 months, 75% of patients on DUPIXENT achieved a >75% improvement in lesion extent and severity (EASI-75) compared to 62% with DUPIXENT at 3 months2-4

Mean EASI score at baseline and review checkpoints*2

At 6 months, a mean EASI score of 3.43 was achieved by 87 patients on DUPIXENT, compared to a mean EASI score of 24.54 at baseline2

Mean DLQI score at baseline and review checkpoints*2

At 6 months, a mean DLQI score of 4.15 was achieved by 81 patients on DUPIXENT, compared to a mean DLQI score of 20.27 at baseline2

A retrospective review of the electronic records of patents receiving DUPIXENT at the Dermatology Centre part of the Salford Royal Hospital NHS Foundation Trust (N=164). Baseline demographics, EASI and DLQI scores were collected at baseline, 3 and 6 months.2,3

CAFÉ trial design: A 16-week, Phase 3, double-blind, randomised, placebo-controlled trial of adults with moderate-to-severe AD, who are inadequately controlled by, or intolerant of ciclosporin. A total of 325 patients in Europe were randomised into three treatment groups in the 16-week study to receive either DUPIXENT 300 mg + TCS QW, DUPIXENT 300 mg + TCS Q2W (licensed dose) or placebo + TCS. Patients applied moisturisers at least twice daily for the seven days prior to randomisation and throughout the study; stable doses of prescription moisturisers or moisturisers containing additives were permitted if initiated before screening.4


The primary endpoint was the proportion of patients that achieved a 75% or greater improvement in the EASI-75 score at 16 weeks from baseline.4


Secondary endpoints included: measures of the impact of DUPIXENT on the persistent itch caused by the disease, health-related quality of life measures, and symptoms of anxiety and depression. A clinically meaningful improvement in pruritus is defined as a ≥4-point improvement in NRS. A clinically meaningful improvement in quality of life is defined as ≥4-point improvement on a 0–30 scale in DLQI.4

  • Learn more about CAFÉ efficacy data, including itch and quality of life

*An EASI score is based on a clinician’s weighted score (0 to 72) of four affected areas grading the physical signs of AD (erythema, oedema/papulation, excoriation, lichenification).5–9
The DLQI score is based on a 10-item patient questionnaire that assesses six different aspects that may affect quality of life. These aspects are symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each question is scored from 0 (not at all) to 3 (very much) and then totalled for the final score.5–9


AD, atopic dermatitis; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; RWE, real world evidence.

References

  1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: December 2020.
  2. Kreeshan F.C, et al. Real-world experience of dupilumab for patients with moderate-to-severe atopic dermatitis in a tertiary care setting (Abstract P095) presented at the 100th British Association of Dermatology, Virtual Congress, September 1 2020.
  3. Kreeshan F.C, et al. Real-world experience of dupilumab for patients with moderate-to-severe atopic dermatitis in a tertiary care setting (Poster P095) presented at the 100th British Association of Dermatology, Virtual Congress, September 1 2020.
  4. de Bruin-Weller M, et al. Br J Dermatol. 2018;178:1083–1101.
  5. Fattah D, et al. Chair’s presentation. Dupilumab for treating moderate to severe atopic dermatitis (ID1048) presented at the 2nd Appraisal Committee meeting lead team presentation, May 10 2018.
  6. © NICE [2018] Dupilumab for treating moderate to severe atopic dermatitis. Available at: https://www.nice.org.uk/guidance/TA534/chapter/1-Recommendations. Date accessed: December 2020. All rights reserved. Subject to notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
  7. Clinical Review Report: Dupilumab (Dupixent): (Sanofi-Aventis Canada Inc.): Indication: Moderate-tosevere atopic dermatitis (AD) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Jul. Appendix 5, Validity of Outcomes Measures. Available at: https://www.ncbi.nlm.nih.gov/books/NBK539234/. Date accessed: December 2020.
  8. EASI User Guide. HOME – Harmonising Outcome Measures for Eczema website. Available at: http://www.homeforeczema.org/documents/easi-user-guide-dec-2016.v2.pdf. Date accessed: December 2020.
  9. Leshem YA, et al. Br J Dermatol. 2015;172(5):1353–1357.